Coronavirus: EU regulator set to approve vaccine by Christmas

A date has been set: On December 21, the EU’s drug regulator is set to make a decision on the BioNTech-Pfizer vaccine, amid political pressure from Berlin. Germany could begin vaccinations before the new year.

The European Union is on track to approve its first COVID-19 vaccine ahead of Christmas. Amid political pressure, the Amsterdam-based European Medicines Agency (EMA) has moved up the expert panel review meeting on the BioNTech-Pfizer vaccine to December 21, eight days sooner than its original deadline of December 29.

The move comes after the UK and the US launched their immunization campaigns in recent days.

“This is good news for the European Union,” said German Health Minister Jens Spahn. “The goal is to achieve European vaccine approval before Christmas and to start vaccinating people in Germany before the turn of the year.”

“Why is this taking so long in Europe?” is a question journalists and citizens are asking. It seems increasingly difficult to come up with an answer as the US Food and Drug Administration, too, released the vaccine last week and the media on Monday reported on the start of the vaccine distribution for health care workers on Long Island. The same is true for Canada, where vaccinations are already underway.

“We are doing everything to ensure that vaccinations can start in December,” Spahn told reporters on Monday. “Every day we can start vaccinating earlier reduces suffering and protects the most vulnerable,” Spahn added. His remarks have made it almost impossible for the EMA to continue the review process without time pressure.

Experts in Brussels have expressed dismay at politicians publicly interfering and going so far out on a limb. “Politicians should be very careful about what they say in public and the expectations they raise concerning the vaccines,” said Yannis Natsis of the European Heath Alliance, an organization on the EMA board. “Above all, we need to keep public confidence in vaccines, and protect public health and safety.”

Speed before diligence?

“The EMA’s careful review process has advantages,” according to Peter Liese, a member of the European Parliament and spokesperson for health of EPP Christian Democrats. “There is a lot of skepticism among the population as to whether a vaccine can really be put on the market that quickly,” said Liese, who monitors anti-vaxxers and their arguments on social media. You need to take these skeptics seriously, and you need to counter their arguments by enabling the best testing possible of the vaccine’s effectiveness and potential side effects, he said.

The MEP explained why EU approval process is lengthier: “The EMA is reviewing more data and going into more depth” when checking effectiveness, side effects and the number of tests. He also said the EMA is working around the clock on the approval for the COVID-19 vaccine, with everything else currently on hold.

Liese said some EMA experts stayed behind when the agency moved from London to Amsterdam last year, but he pointed out it is common practice that national experts, who for months have prepared for this event, join the team. He urged sticking to the present course and not following the UK and US leads and their overnight emergency approval. Among other things, he warned, liability for possible consequential damage would be transferred from the manufacturer, BioNTech-Pfizer, to the EU member states.

As recently as late November, the German Health Minister spoke out in favor of the tried-and-tested EU procedure, saying careful testing was important for confidence in the new vaccine. But it seems he has changed his mind — unlike Yannis Natsis, who said he understands the pressure and the emergency situation, but argued that “we have to be careful, we have to proceed with care — you can’t push this through.”

And he also warned against expecting too much. “Vaccines will not be the miracle cure politicians expect them to be,” he said. And according to Peter Liese, a few weeks either way don’t make much of a difference; Germany won’t find itself “in a different position in the pandemic process in the spring anyway.” The question of what regulations can be eased in January has nothing to do with starting vaccinations as quickly as possible, he said.

Europeans are not at a disadvantage

Liese criticized as untrustworthy reports in Germany’s Bild tabloid — the paper wrote millions of people were getting the German vaccine while Germans themselves had to wait. “The vaccine was produced proportionally, it has already been allocated for Germany, some of it is already frozen and can be delivered at short notice,” he said.

Liese said the approval process may be two to three weeks longer, but that doesn’t mean fewer Germans will be vaccinated.

“I do not believe patients in the EU will be disadvantaged compared to patients in Britain or the US,” Natsis said. In summer 2020, countries all over the world secured doses of promising vaccines, including the one by BioNTech-Pfizer. “The EU Commission acted for Europe and bought 400 million doses, which is enough for 200 million citizens because everyone needs to be vaccinated twice,” he said.